Massachusetts antes up with tough transparency law

Massachusetts passed regulation governing drug and device company sales and marketing that the state's deputy counsel boasted is “the most stringent of the existing state laws” and “sets PhRMA and AdvaMed codes as the floor.”

The Massachusetts Public Health Council's Pharmaceutical and Medical Device Manufacturer Conduct law requires that starting July 1, companies provide annual reports on all payments or other transfers of value to healthcare professionals worth more than $50. The law features an expansive definition of sales and marketing practices. It bans gifts such as pens and coffee mugs, prohibits drug and device manufacturers from buying physicians lavish meals outside of the office, and bars sponsorship or payment for CME that does not meet the ACCME Standards of Commercial Support.

Manufacturers are also prohibited from providing financial support to practitioners in training. Before they can use prescriber data for marketing purposes, they must give practitioners the opportunity to request that their data be withheld from sales reps and marketers. Companies can be fined up to $5,000 for each “knowing and willful” violation of the regs.

Exempted from disclosure are payments to healthcare professionals for “genuine research projects and clinical trials,” along with samples.

The governor's office said in a release that the rules “place Massachusetts at the forefront nationally in monitoring the relationship between industry and health care providers, and will be the strictest in the nation in mandating reporting and public disclosure of certain fees, payments and other compensation provided by companies to physicians.”